The Director, Clinical Pharmacology/Pharmacometrics will join a dedicated team of clinical development professionals and be responsible for all aspects of clinical pharmacology with focus on PKPD, population PKPD and regulatory interactions. They will be instrumental in dose selection and dose optimization efforts through analyses of PKPD data. They will be interfacing with various groups internally and externally with CROs and alliance partners to ensure proper support for programs and studies. The individual in this role will work with minimal supervision and participate in KOL and regulatory meetings. They will provide strategic and scientific direction and be diligent in delivery of key CP project goals.
- Lead pharmacometric aspects of clinical development plans across multiple projects.
- Hands on pharmacometric modeling, including exposure-response, disease modeling, and population modeling.
- Serve as a primary source of scientific support for the design, analysis, reporting, and presentation of pharmacokinetic and pharmacodynamic results from clinical studies.
- Contribute to clinical study designs including first-in-human, human mass balance, bioavailability and/or bioequivalence and drug-drug interaction studies.
- Develop submission ready summaries of modeling results and interpretations for regulatory documents (IND, NDA, IB, etc).
- Familiarity of FDA and EMA, and ICH guidance documents including GXp regulations on current practices in the areas of POPPK, PKPD, ADME and clinical pharmacology.
- Responsible for contributing pharmacometric and clinical pharmacology components of regulatory submissions and responses to questions from regulatory agencies.
- Oversight of M&S CROs and consultant relationships to ensure capacity to respond to program needs at all stages of development
- Candidate is expected to work independently with minimal supervision. Mentor colleagues in the department.
- Strong communication, organizational and interpersonal skills, and ability to manage projects and team members in a matrix environment.
- PhD. in pharmacokinetics or related discipline with 5 to 8 years of relevant industrial experience
- Experience (1-2 years) demonstrating regulatory submission with NDA and INDs and responses to regulatory clinical pharmacology/pharmacometric questions.
- Strong scientific background in pharmacokinetics, pharmacodynamics and drug disposition sciences
- Experience in population PK, PKPD, M&S utilizing software such as NONMEM, Monolix, R, Gastroplus/Simcyp/PKSim is desirable.
- Experience working with external vendors and CROs.
- Problem solving and organizational skills with attention to detail. Strong team player and strong motivational skills.